FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims to assist and provide recommendations to industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notifications for firm‑initiated or FDA‑requested recalls. In addition, the guidance discusses what information to include in a public warning, as well as the parties responsible for issuing it. Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages. Comments on the draft guidance are due by March 20, 2018.

The draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C,” states that FDA’s policy is to evaluate the circumstances of each recall to determine whether a pubic warning is needed. A public warning shall alert the public that a recalled product presents a serious health hazard. It is reserved for urgent situations where other means of preventing use of the recalled product appear inadequate. The guidance explains that Class I recalls (where there is a reasonable probability that use or exposure will cause serious harm or death) generally will require a public warning. As an example, a public warning is often needed when a recalled product has been widely distributed. By contrast, when recalled products have only been distributed to direct accounts and the recalling firm has records that show exactly where the product has gone, a prompt and initial oral communication to such accounts informing them of the recall may be adequate to prevent the use of a recalled product. This could be an instance where the product has only reached the wholesale level, such as a warehouse or distribution center, and has not been further distributed to the retail or consumer level. In addition, some urgent Class II recalls (where use or exposure may cause temporary or medically reversible adverse health consequences or where there is a remote probability of serious adverse health consequences) may also necessitate a public warning if a product presents a serious hazard to health.

The draft guidance explains that recalls of the following types of food products would generally present examples of serious hazards to health, meriting a public warning:

If a firm has received consumer reports of illness or injury;

If there is an active outbreak associated with the product or its ingredients;

The draft guidance does not discuss all types of recalls due to manufacturing deviations, such as recalls due to glass fragments in beverage containers. The draft guidance explains who should prepare a public warning, the type of information that such a warning should contain, and when the agency will consider a public warning to be deficient.

The draft guidance contemplates the issuance of a public warning through a press release or a press release distribution service, but leaves open the possibility that other “vehicles of dissemination” may best convey information for particular recalls. It is unclear if such vehicles would include social media, emails, text alerts or other actions intended to inform consumers. FDA emphasizes that responsible firms must make earnest efforts to ensure recall information is actually distributed on a national or regional basis, as appropriate, and in multiple languages if necessary.

FDA also announced that it will now include in in its weekly Enforcement Report recalls that the agency has not yet classified as Class I, II or III (use or exposure is not likely to cause adverse health consequences). The Enforcement Report provides a public listing of products subject to a recall. Unlike with public warnings, the Enforcement Report does not limit reported incidents to urgent situations that present serious hazards to health. FDA includes recalls for FDA-regulated alcohol beverages (e.g., wines less than 7 percent alcohol by volume, most “hard seltzers”) in the Enforcement Report, whether the recall requires a public warning or not. For example, the Enforcement Report has included recalls of hard apple cider because the bottles may explode. The Enforcement Report will note that a recall is not yet classified or list the recalls as Class I, II or III, depending on the severity of the health hazard posed by the recalled product. The Enforcement Report makes available to the public information about each recall, including product descriptions, the reason for the recall and the specific actions that the recalling company is pursuing. Notably, FDA is not required to provide a firm with an opportunity to review or comment on the information the agency includes in its Enforcement Report.

Additionally, FDA Commissioner Scott Gottlieb announced that the agency is planning a “new approach to the release of recall information this year,” but did not provide further details. Dr. Gottlieb has indicated that FDA is examining in what situations FDA can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food and what company may have supplied the product. If FDA can disclose this information, FDA believes consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if consumed.

Vanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows’ full bio.

Christopher (Chris) M. Lahiff advises clients on matters regarding the regulation of pesticides by the US Environmental Protection Agency as well as of food by the US Food and Drug Administration and the US Department of Agriculture. Read Chris Lahiff’s full bio.